Ketamine vs Propofol for Sedation During Pediatric Bronchoscopy

NCT02743104 | Suspended

• 1 other identifier: KP-001
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether ketamine or propofol, drugs used for procedural sedation during paediatric bronchoscopy, results in higher operator satisfaction and better side effect profile.

Conditions

Paediatric Flexible Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• Overall Pulmonologist's satisfaction level (VAS)

  Assessed via visual analog scale

  2 years

Secondary Outcomes (2)

• Amount of airway secretions

  2 years

• Cough score

  2 years

Study Arms (2)

Ketamine for procedural sedation

ACTIVE COMPARATOR

All patients will be sedated according to a written protocol which includes intravenous administration of midazolam and atropine. In addition, local anesthesia will be performed using lidocaine 1% sprayed once just above the vocal cords, and again at the level of the carina. Lidocaine doses are limited to a maximum total dose of 5mg/kg. This study group will be exposed to ketamine as the main drug for sedation, as an initial bolus of 1-2 mg/kg initially and then titrated by additional doses of 1mg/kg per dose.

Drug: Ketamine; Drug: midazolam and atropine; Drug: Lidocaine

Propofol for procedural sedation

ACTIVE COMPARATOR

All patients will be sedated according to a written protocol which includes intravenous administration of midazolam and atropine. In addition, local anesthesia will be performed using lidocaine 1% sprayed once just above the vocal cords, and again at the level of the carina. Lidocaine doses are limited to a maximum total dose of 5mg/kg. This study group will be exposed to propofol as the main drug for sedation, as an initial bolus of 1-2 mg/kg initially and then titrated by additional doses of 1mg/kg per dose.

Drug: Propofol; Drug: midazolam and atropine; Drug: Lidocaine

Interventions

Ketamine DRUG

Also known as: Ketalar

Ketamine for procedural sedation

Propofol DRUG

Also known as: Diprivan

Propofol for procedural sedation

midazolam and atropine DRUG

Ketamine for procedural sedation; Propofol for procedural sedation

Lidocaine DRUG

Ketamine for procedural sedation; Propofol for procedural sedation

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children undergoing flexible bronchoscopy

You may not qualify if:

• Failure to acquire parental consent
• Bronchoscopies performed outside of the bronchoscopy suite
• Bronchoscopies performed under general anesthesia with a protected airway
• Bronchoscopies performed by personnel outside of the study group
• Known allergies to either of the sedation drugs used

Sponsors & Collaborators

• Rabin Medical Center: lead

Related Publications (4)

• Hwang J, Jeon Y, Park HP, Lim YJ, Oh YS. Comparison of alfetanil and ketamine in combination with propofol for patient-controlled sedation during fiberoptic bronchoscopy. Acta Anaesthesiol Scand. 2005 Oct;49(9):1334-8. doi: 10.1111/j.1399-6576.2005.00842.x.

  PMID: 16146472 BACKGROUND

• Dal T, Sazak H, Tunc M, Sahin S, Yilmaz A. A comparison of ketamine-midazolam and ketamine-propofol combinations used for sedation in the endobronchial ultrasound-guided transbronchial needle aspiration: a prospective, single-blind, randomized study. J Thorac Dis. 2014 Jun;6(6):742-51. doi: 10.3978/j.issn.2072-1439.2014.04.10.

  PMID: 24976998 BACKGROUND

• Wahidi MM, Jain P, Jantz M, Lee P, Mackensen GB, Barbour SY, Lamb C, Silvestri GA. American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients. Chest. 2011 Nov;140(5):1342-1350. doi: 10.1378/chest.10-3361.

  PMID: 22045879 BACKGROUND

• Stolz D, Chhajed PN, Leuppi J, Pflimlin E, Tamm M. Nebulized lidocaine for flexible bronchoscopy: a randomized, double-blind, placebo-controlled trial. Chest. 2005 Sep;128(3):1756-60. doi: 10.1378/chest.128.3.1756.

  PMID: 16162784 BACKGROUND

MeSH Terms

Interventions

Ketamine; Propofol; Midazolam; Atropine; Lidocaine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2016
• First Posted: April 19, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: April 28, 2017

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share